SAR 421869

Drug Profile

SAR 421869

Alternative Names: MY07A gene therapy - Oxford Biomedica; Myosin VIIA gene therapy; SAR-421869; Usher syndrome gene therapy - Oxford BioMedica/Sanofi; UshStat

Latest Information Update: 16 Sep 2015

Price : $50

At a glance

  • Originator Oxford BioMedica
  • Developer Sanofi
  • Class Gene therapies
  • Mechanism of Action Gene transference
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Usher syndromes
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Usher syndromes

Most Recent Events

  • 16 Sep 2015 Phase-I/II development for Usher syndromes is ongoing in USA and France
  • 14 Feb 2014 Oxford BioMedica intiates enrolment by invitation only in a follow up phase I trial to assess the long term safety of MY07A gene therapy (NCT02065011)
  • 17 Oct 2013 Oxford BioMedica reaches an agreement with the US FDA to resume recruitment into the phase I/IIa trial for Usher syndromes in USA
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